Whitepapers and eBooks

Are you interested in the shift in manufacturing to non-US/EU facilities and the significant challenges presented to ensuring both the quality of the supply chain and timeliness of receiving products intended for clinical or commercial distribution? Learn more about the emerging changes to the standard interpretation of laws governing...

The National Cancer Institute (NCI) estimates that only approximately 3% of US adult cancer patients participate in clinical trials. The low participation rate is a major bottleneck in developing new cancer treatments. Clearly a key factor in progress toward better treatment and prognosis in adult oncology lies in improving participation rates...

Digital clinical research organizations (dCROs) distinguish themselves from traditional CROs by utilizing innovative, technology-amplified processes to deliver more efficient and effective clinical trial management services.  Clinipace's proprietary TEMPO™ eClinical platform transforms the way that clinical research is managed by increasing efficiency and, thus, decreasing costs. Every member of the study team, whether employed by the sponsor, CRO, or site, has real-time access to the same information and data. 

The accelerated number, pace, and globalization of clinical trials today have made trial management and monitoring far more complex and costly. On-site clinical trial monitoring alone is estimated to account for up to 30 percent of study costs.  Given the significant investment in time, resources, and money spent on monitoring activities, trial sponsors must make sure their CROs are using the best, most efficient risk-based monitoring methods for study oversight and quality assurance.

With the ever-increasing pressure on pharmaceutical and biotechnology companies to bring more products to market faster while also cutting costs, many in the industry have turned their focus to streamlining study start-ups. 

Cardiovascular diseases are the number one cause of death worldwide, and today’s rich biopharmaceutical pipeline holds more than 350 experimental cardiovascular agents.  To conduct successful multinational studies, sponsors must ensure consistency across varying regulatory requirements and standards of care as they manage trial operations country-by-country.

Approximately 20% of the world’s clinical trials are conducted in Europe, which is defined in this context as the 30 countries that contribute to the European Medicines Agency (EMA).  Compared with single countries, such as the US or Japan, the confederation of separate nations that comprise Europe can present both challenges and opportunities for clinical trials at any stage of drug development.

Advances in biotechnology will continue to expand the potential for new therapeutics in oncology. Translating in vitro data into an approved clinical regimen will continue to be challenging, especially as targeted therapies add complexity to designing studies and assessing effectiveness. However, several strategies, including developing a solid study design, choosing the right study team, and using technology, can help streamline the conduct of trials and improve quality of data.

For medical devices, good engineering does not guarantee clinical trial or commercial success. The climate for introducing new medical devices into the market has become increasingly difficult in recent years. Executing a successful market strategy involves navigating the approval process, designing and conducting efficient clinical trials, adeptly evaluating the existing marketplace.

In developing treatments for neurologic disorders, researchers and clinicians face several challenges related to both disease state and conducting clinical trials. However, ongoing developments in basic science and in efficient capture and sharing of data are creating opportunities for advancing the treatment landscape.